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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001363
Receipt No. R000001553
Scientific Title Post-marketing Clinical Trial of Pioglitazone - A Study of Preventive Effects on the Onset and Recurrence of Macrovascular Events -
Date of disclosure of the study information 2008/09/10
Last modified on 2009/01/22

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Basic information
Public title Post-marketing Clinical Trial of Pioglitazone - A Study of Preventive Effects on the Onset and Recurrence of Macrovascular Events -
Acronym Post-marketing Clinical Trial of Pioglitazone - A Study of Preventive Effects on the Onset and Recurrence of Macrovascular Events -
Scientific Title Post-marketing Clinical Trial of Pioglitazone - A Study of Preventive Effects on the Onset and Recurrence of Macrovascular Events -
Scientific Title:Acronym Post-marketing Clinical Trial of Pioglitazone - A Study of Preventive Effects on the Onset and Recurrence of Macrovascular Events -
Region
Japan

Condition
Condition Type2 Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The preventive effects of pioglitazone on the onset and recurrence of macrovascular events in type 2 diabetes mellitus patients were exploratory investigated using pioglitazone-untreated patients as the control group.
Basic objectives2 Others
Basic objectives -Others [1] Using the carotid intima-media thickness (IMT) as the index, the prevention of arteriosclerosis by pioglitazone in type 2 diabetes mellitus patients was investigated using pioglitazone-untreated patients as the control group.
[2] The long-term safety of pioglitazone in type 2 diabetes mellitus patients was investigated.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to the onset of any of the following macrovascular events from the start of the treatment period (Week 0):
[1]Death (endogenous)
[2]Myocardial infarction (non-fatal)
[3]Silent myocardial infarction
[4]Acute coronary syndrome
[5]Coronary intervention (percutaneous vascular intervention, coronary artery bypass surgery)
[6]Cerebrovascular disorder (excluding TIA)
[7]Lower limb (leg down to the ankle) amputation
[8]Lower limb bypass surgery or angioplasty
[9]Onset or worsening of angina pectoris
[10]Arteriosclerosis obliterans
Key secondary outcomes Changes in IMT, occurrence of adverse events (subjective and objective concurrent symptoms, abnormal changes in laboratory values)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In addition to their baseline treatment, Pioglitazone 15 to 30 mg was orally administered once daily before or after breakfast.The dosage was adjusted according to the patient's sex, age and symptoms, up to the maximum daily dose of 45 mg.Concerning the use of pioglitazone in women or elderly patients, it was recommended to start treatment at 15 mg once daily. When it became necessary to start insulin therapy, the treatment with pioglitazone was to be suspended. If the insulin therapy was discontinued thereafter, the treatment with pioglitazone was to be resumed again if possible.The duration of treatment was set at 2.5 to 4 years.
Interventions/Control_2 Their baseline treatment was kept.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
35 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria (1)Subjects whose HbA1c was 6.5% or more
(2)Subjects who met at least two of the following conditions
1)Subjects with hypertension (those who met one of the following conditions)
[1]Subjects who were diagnosed with hypertension and who had been on drug therapy
[2]Subjects who had not received drug therapy and showed a systolic blood pressure of 140 mmHg or more ,or a diastolic blood pressure of 90 mmHg or more at rest in the sitting position.
2)Subjects with hyperlipidemia (including abnormality of lipid metabolism) (those who met one of the following conditions)
[1]Subjects who were diagnosed with hyperlipidemia and who had been on drug therapy
[2] Subjects who had not received drug therapy and showed a total cholesterol of 240 mg/dL or more, LDL-cholesterol of 160 mg/dL or more, or HDL-cholesterol of 40 mg/dL or less.
3)Subjects with a smoking habit (at least one cigarette/day)
4) Obesity (BMI 25 or more)
Key exclusion criteria (1)Subjects who were diagnosed with type 1 diabetes mellitus
(2)Subjects with a BMI of <22 and a fasting IRI of <5 mU/mL
(3)Subjects who required insulin therapy to control the blood glucose of diabetes mellitus, or who were on insulin therapy
(4)Subjects with a history of hepatic function disorder due to the use of thiazolidinediones (e.g., troglitazone and pioglitazone)
(5)Subjects currently on pioglitazone therapy
(6)Subjects who had cardiac failure or a history thereof
(7)Subjects with cardiovascular disorders (those who met the following conditions)
1)Subjects with onset of myocardial infarction within 6 months
2)Subjects who received hospital treatment for acute coronary syndrome within 3 months
3) Subjects who underwent coronary artery bypass surgery or percutaneous transluminal coronary angioplasty within 6 months
(8)Subjects with the complication of severe arrhythmia
(9)Subjects with cerebrovasculardisorders [those with onset of cerebrovascular disorder (excluding TIA)]
(10)Subjects who needed management of their blood glucose by insulin injection, due to severe infection, before or after operation, or serious traumatic injury
(11)Subjects with scheduled coronary artery bypass surgery, percutaneous transluminal coronary angioplasty, or surgery for leg ischemia
Target sample size 550

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohei Kaku
Organization Kawasaki Medical School
Division name Diabetes and Endocrine Division, Department of Medicine
Zip code
Address 577 Matsushima Kurashiki-shi, Okayama,Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Takeda Pharmaceutical Company Limited
Division name Contact for Clinical Trial Infomation
Zip code
Address
TEL
Homepage URL https://www.takeda.co.jp/contact/form/jp/form/
Email

Sponsor
Institute Takeda Pharmaceutical Company Limited
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 09 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2001 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2002 Year 04 Month 01 Day
Last follow-up date
2006 Year 06 Month 01 Day
Date of closure to data entry
2006 Year 08 Month 01 Day
Date trial data considered complete
2006 Year 08 Month 01 Day
Date analysis concluded
2006 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 09 Month 09 Day
Last modified on
2009 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001553

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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